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Medela is Committed to Providing the Highest Quality Products

March 8, 2011 - As part of our dedication to providing the highest quality products, Medela has initiated enhancements to our quality management system, including implementing new standards and upgrading our facilities. This letter is a result of visits from an FDA inspector in 2010. Since that time, Medela has already made significant improvements to address the issues raised and will provide this information to the FDA in the very near future.

Mother and baby safety is always a foremost concern for Medela. Since its 2003 launch, more than a million Pump in Style Advanced (PNSA) breastpumps have been safely used by mothers worldwide with no reports of injury related to the power adapter (also called the transformer) or motor. There have been no confirmed incidents of fire or injury related to the pump motor. The power adapter is UL-approved for use with the PNSA and instructions provided include warning statements regarding its use. If the power adapter cord is damaged, it can lead to overheating, loss of operation or, in very rare cases, smoking and/or sparking of the power adapter. As stated in our PNSA instructions, moms should not use damaged power adapters. Should a mom’s power adapter become compromised, Medela Customer Service will replace it (customer.service@medela.com). As a company committed for 30 years to supporting breastfeeding mom and their babies, Medela holds itself to the highest standards for quality, safety and customer service.
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